Supplementation Trial of KOKO Plus Among HIV Exposed Children in Accra

NCT04995874 | Unknown DMC

• 1 other identifier: 2021X018.NMI
• Study Type: interventional
• Target: 649
• Locations: 1 country
• Sites: 6

Brief Summary

The overall aim of the research is to conduct a randomised controlled trial of KOKOPlus in young HIV exposed children attending HIV clinics in Accra, Ghana to test the effectiveness of KOKOPlus over a period of 6 months to improve nutritional status and child development in HIV exposed children 6-18 months of age in Accra

Conditions

HIV Infections; Nutrition Poor; Child Development

Keywords

HIV-Exposed; Nutrient Status; KOKOPlus

Outcome Measures

Primary Outcomes (3)

• Anthropometry

  Length-for-age Z score, Weight-for-age Z score. Weight for length Z score

  6 months

• Haemoglobin

  (g/dl), anaemia

  6 months

• Child developmental Milestones achieved

  6 months

Secondary Outcomes (1)

• Morbidity

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

KOKOPlus protein and micronutrient powder , a complementary food supplement containing soya powder, sugar and oil along with the essential amino acid lysine and a micronutrient mix was formulated. Two weeks' supply of KOKOPlus sachets will be given to intervention arm participants every fortnight for 6 months to be mixed into any cereal, soup, stew, or other food given to the children.

Dietary Supplement: KOKOPlus protein and micronutrient powder

Control

NO INTERVENTION

This arm will receive no supplement and no placebo for the duration of the study.,

Interventions

KOKOPlus protein and micronutrient powder DIETARY_SUPPLEMENT

KokoPlus, a complementary food supplement was formulated by using linear programming methodology to improve the protein quality as well as the micronutrient and macronutrient content of commonly consumed traditional complementary (baby) foods in Ghana . It contains soya powder, sugar and oil along with the essential amino acid lysine and a micronutrient mix. It complies with WHO's complementary feeding guidelines, FAO/WHO recommended micronutrient intake (RNI) and the WHO's guidelines for protein and essential amino acid intake for children in the age group of 6 to 24 months. A daily supply of KokoPlus achieves 30% of the total recommended energy, 60% of total protein and 40% of total fat requirements from complementary foods. It also meets 35-55% of minimum intake of essential amino acids and 50-150% RNI based on the total daily requirements.

Intervention

Eligibility Criteria

• Age: 6 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Mother-infant dyads; HIV positive mothers and children between 6 and 12 months of age attending antiretroviral (ART) Clinics and child HIV Clinics.

You may not qualify if:

• Mothers who decline to participate in the study
• Children with severe acute malnutrition (mid-upper arm circumference \<115 mm or a weight-for-height/length \<-3 Z-scores of the WHO growth standards).
• Children on hospital admission
• Children with diagnosed or apparent congenital conditions such as encephalitis, cleft palate, hole in heart, which negatively affect the child's ability to eat and/or growth.

Sponsors & Collaborators

• Noguchi Memorial Institute for Medical Research: lead
• International Food Policy Research Institute: collaborator

Study Sites (6)

37 Military Hospital

Accra, Greater Accra Region, Ghana

RECRUITING

Greater Accra Regional Hospital

Accra, Greater Accra Region, Ghana

RECRUITING

Korle-bu Teaching Hospital

Accra, Greater Accra Region, Ghana

RECRUITING

Princess Marie Louise Children's Hospital

Accra, Greater Accra Region, Ghana

RECRUITING

Ashaiman Polyclinic

Ashaiman, Greater Accra Region, Ghana

RECRUITING

Tema General Hospital

Tema, Greater Accra Region, Ghana

RECRUITING

MeSH Terms

Conditions

HIV Infections; Malnutrition

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Gloria K Folson

  Noguchi Memorial Institute for Medical Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gloria K Folson

CONTACT

+233550006053; gfolson@noguchi.ug.edu.gh

Grace S Tokor

CONTACT

+233243009116; gracetokor@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 9, 2021
• Study Start: August 6, 2021
• Primary Completion: June 25, 2022
• Study Completion: June 25, 2022
• Last Updated: November 15, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GH (6)